Establishing national pharmacovigilance programs MCQs With Answer

Establishing national pharmacovigilance programs is essential for systematic drug safety monitoring, adverse drug reaction (ADR) reporting, and risk management across healthcare systems. For B.Pharm students, understanding regulatory frameworks, spontaneous and active surveillance, signal detection, causality assessment (WHO‑UMC, Naranjo), and data sources like VigiBase equips you to contribute to patient safety. Key components include national PV centers, reporting forms, electronic ICSRs, MedDRA coding, periodic safety update reports (PSUR/PBRER), and collaboration with regulatory authorities. Practical knowledge of pharmacovigilance processes, audit, and communication of safety decisions strengthens professional competence. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary objective of a national pharmacovigilance program?

• To promote sales of new medicines
• To monitor and ensure the safety of medicines in the population
• To develop new drugs
• To replace clinical trials

Correct Answer: To monitor and ensure the safety of medicines in the population

Q2. Which international database collects Individual Case Safety Reports (ICSRs) from national pharmacovigilance centers?

• ClinicalTrials.gov
• VigiBase
• PubMed
• EMA Archive

Correct Answer: VigiBase

Q3. Which organization coordinates the WHO international drug monitoring program?

• Uppsala Monitoring Centre (UMC)
• Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• World Trade Organization (WTO)

Correct Answer: Uppsala Monitoring Centre (UMC)

Q4. Which method is primarily used for spontaneous reporting of adverse drug reactions?

• Cohort event monitoring
• Randomized controlled trials
• Spontaneous/voluntary reporting by healthcare professionals and patients
• Meta-analysis

Correct Answer: Spontaneous/voluntary reporting by healthcare professionals and patients

Q5. Which causality assessment method is commonly used in national PV centers and WHO collaborations?

• Naranjo algorithm
• WHO‑UMC causality categories
• Bradford Hill criteria only
• Kaplan‑Meier method

Correct Answer: WHO‑UMC causality categories

Q6. What does ICSR stand for in pharmacovigilance?

• International Clinical Safety Review
• Individual Case Safety Report
• Immediate Causality Safety Record
• Integrated Clinical Safety Report

Correct Answer: Individual Case Safety Report

Q7. Which coding dictionary is widely used for adverse event terminology in pharmacovigilance?

• ICD‑10
• MedDRA
• SNOMED CT
• LOINC

Correct Answer: MedDRA

Q8. What is a pharmacovigilance signal?

• A guaranteed adverse reaction causally proven by RCTs
• Information suggesting a new or changing causal association between a drug and an adverse event
• A marketing term for side effects
• A statistical method for clinical trial design

Correct Answer: Information suggesting a new or changing causal association between a drug and an adverse event

Q9. Which report summarizes safety data periodically for marketed drugs and is required by regulators?

• Investigator’s Brochure
• Periodic Safety Update Report (PSUR) / PBRER
• New Drug Application
• Clinical Study Report

Correct Answer: Periodic Safety Update Report (PSUR) / PBRER

Q10. Which surveillance method actively follows a defined cohort to identify adverse events after drug exposure?

• Spontaneous reporting
• Cohort event monitoring
• Case report only
• Systematic review

Correct Answer: Cohort event monitoring

Q11. Which term describes an adverse event that results in death, is life‑threatening, requires hospitalization, or causes persistent disability?

• Serious adverse event
• Non‑serious adverse event
• Minor adverse reaction
• Expected side effect

Correct Answer: Serious adverse event

Q12. Which stakeholder is primarily responsible for reporting ADRs to the national pharmacovigilance center?

• Pharmaceutical sales representatives
• Healthcare professionals and sometimes patients
• Only the drug manufacturer
• Insurance companies

Correct Answer: Healthcare professionals and sometimes patients

Q13. What is the role of a Risk Management Plan (RMP) in pharmacovigilance?

• To plan marketing strategies
• To describe known/possible risks and measures to minimize them
• To replace clinical safety data
• To define pricing policy

Correct Answer: To describe known/possible risks and measures to minimize them

Q14. Which of the following is a limitation of spontaneous ADR reporting?

• High sensitivity for detecting all ADRs
• Underreporting and reporting bias
• Always provides reliable incidence rates
• Eliminates need for post‑marketing studies

Correct Answer: Underreporting and reporting bias

Q15. Which document should be submitted by marketing authorization holders to regulators when a new safety concern emerges?

• Annual financial report
• Safety signal assessment and risk minimization proposal
• Marketing plan
• Investigator’s brochure only

Correct Answer: Safety signal assessment and risk minimization proposal

Q16. What is VigiFlow?

• A clinical trial randomization tool
• A web‑based ICSR management system used by national PV centers
• A marketing analytics platform
• An adverse event coding dictionary

Correct Answer: A web‑based ICSR management system used by national PV centers

Q17. Which analytical method helps detect disproportional reporting of drug‑event pairs in databases?

• Disproportionality analysis (e.g., PRR, ROR)
• Kaplan‑Meier survival analysis
• ANOVA
• Fisher’s exact test only

Correct Answer: Disproportionality analysis (e.g., PRR, ROR)

Q18. Which of the following best describes pharmacovigilance in clinical trials?

• Monitoring only efficacy outcomes
• Systematic collection, assessment and reporting of adverse events during clinical trials
• Marketing surveillance post‑approval only
• Only laboratory safety monitoring

Correct Answer: Systematic collection, assessment and reporting of adverse events during clinical trials

Q19. Which agency is primarily responsible for drug safety regulation in India?

• FDA (United States)
• Central Drugs Standard Control Organization (CDSCO)
• EMA (European Medicines Agency)
• MHRA (UK)

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q20. What does PSUR stand for?

• Periodic Safety Update Report
• Product Safety Usage Record
• Pharmacovigilance Safety Utility Report
• Post‑marketing Study Unique Report

Correct Answer: Periodic Safety Update Report

Q21. Which activity helps validate a suspected ADR report before further assessment?

• Immediate public release without verification
• Case triage and follow‑up for missing information
• Assuming causality and closing the case
• Deleting duplicate reports without review

Correct Answer: Case triage and follow‑up for missing information

Q22. Which of the following is an example of active pharmacovigilance?

• Voluntary spontaneous reporting
• Targeted follow‑up studies like cohort event monitoring
• Advertising adverse effects to the public
• Ignoring reports from patients

Correct Answer: Targeted follow‑up studies like cohort event monitoring

Q23. Who can submit an ADR report in many national PV systems?

• Only physicians
• Healthcare professionals and patients or caregivers
• Only pharmacists
• Only regulatory inspectors

Correct Answer: Healthcare professionals and patients or caregivers

Q24. What is the Naranjo algorithm used for?

• Identifying drug manufacturing defects
• Quantitative causality assessment for ADRs
• Measuring drug blood levels
• Designing clinical trials

Correct Answer: Quantitative causality assessment for ADRs

Q25. Which of the following best reflects a regulatory action that may follow a confirmed safety signal?

• Ignorance of the signal
• Label changes, black box warning, restriction or market withdrawal
• Immediate prosecution of prescribers
• Increasing promotional activities

Correct Answer: Label changes, black box warning, restriction or market withdrawal

Q26. Which data source is important for pharmacoepidemiology studies supporting national PV programs?

• Electronic health records and claims databases
• Only spontaneous reports without denominator data
• Marketing brochures
• Only preclinical animal studies

Correct Answer: Electronic health records and claims databases

Q27. What is the purpose of MedDRA coding in pharmacovigilance?

• To encrypt patient identifiers
• To standardize adverse event terminology for analysis and reporting
• To classify dosage forms
• To manage drug pricing

Correct Answer: To standardize adverse event terminology for analysis and reporting

Q28. Which performance indicator is useful to assess a national PV program?

• Number of ICSRs received per year and quality of reports
• Number of drugs approved each year only
• Total pharmaceutical sales revenue
• Number of conference presentations

Correct Answer: Number of ICSRs received per year and quality of reports

Q29. Which element is essential for effective pharmacovigilance communication to healthcare professionals and the public?

• Delay and minimal transparency
• Clear, timely and evidence‑based safety information
• Use of technical jargon only
• Unverified rumors

Correct Answer: Clear, timely and evidence‑based safety information

Q30. How can B.Pharm graduates contribute to national pharmacovigilance programs?

• By only selling medicines
• By participating in ADR reporting, signal detection, database management and patient counselling
• By avoiding any involvement with ADRs
• By conducting only animal studies

Correct Answer: By participating in ADR reporting, signal detection, database management and patient counselling

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